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ISRCTN
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ISRCTN89168782
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ClinicalTrials.gov identifier
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Public title
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The Bronchodilator Effect of Ultrafine Particles of Salbutamol
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0265126517
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Study hypothesis
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Do ultrafine particles of inhaled salbutamol generated from a standard nebulised dose (2.5 mg) cause measurable bronchodilation in patients with asthma?
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Double blind random order placebo-controlled accumulative dose response study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Respiratory: Asthma
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Participants - inclusion criteria
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1. Age >18 years
2. The presence of mild to moderate asthma
3. Willingness and ability to give written informed consent
Potential volunteers will be identified from two sources; prospectively from patients attending Dr D Thickett's respiratory out-patient clinics at UHB trust, and from poster advertisements displayed in the staff common rooms of the Trusts critical care units. In each case, interested parties will be invited to contact the principal investigator by phone to discuss possible participation further. If they would still like to consider participation they will be sent a volunteer information sheet, a copy of the consent form and a 'reply paid' slip by mail. On receipt of the reply slip, the principal investigator will contact them again by phone to arrange a mutually convenient date for them to attend for the first study day. Formal informed written consent will be obtained when participants attend for the first study day. At no time will the participants be pressurised into taking part in any way. No inducements will be offered, but traveling expenses will be refunded if requested.
Participants will be asked if they would like their general practitioners to be informed of their participation in the study. If so, a letter explaining the study and detailing the individual's participation will be sent by first class post to the general practitioner on the first study day.
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Participants - exclusion criteria
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1. The use of > 1000 mcg Beclomethasone (or equivalent) per day
2. Unstable asthma
3. Inability or unwillingness to discontinue long acting and oral bronchodilators for 24 hours, and all short acting bronchodilators for 4 hours prior to each study.
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Anticipated start date
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05/09/2003
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Anticipated end date
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05/09/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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8 adult volunteers
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Interventions
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This is a double blind, random order, placebo-controlled accumulative dose response study exploring the bronchodilator effects of ultrafine particles of salbutamol in a group of subjects with asthma. The placebo limb will use ultrafine particles of 0.9% saline, generated in an identical way to the active (salbutamol) aerosol.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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University Hospital Birmingham NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Dr
W S
Tunnicliffe
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Address
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Respiratory Medicine
Selly Oak Hospital
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City/town
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Birmingham
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Zip/Postcode
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B29 6JD
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Country
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United Kingdom
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Tel
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+44 (0)121 627 1627
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Email
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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03/11/2011
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Date ISRCTN assigned
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30/09/2004
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